Name: Predicase
Price: 199 USD

K-number	K192679
Device name	Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use
Applicant	Gemtier Medical (Shanghai), Inc.
Product code	MEG
Device class	Class II
Decision date	Apr 10, 2020
Decision	Substantially Equivalent
Regulation	880.5860

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Source

View the full FDA submission: accessdata.fda.gov

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Sterile Syringe with Safety needle for Single Use, Sterile Syringe for Single Use, Sterile Safety Needle for Single Use

Everything you need for a 510(k) submission. Nothing you don't.